Hi, ** **
Hope you are doing great! Please find the requirement below , If you find yourself comfortable with the requirement please reply back with your *updated resume *and I will get back to you or I would really appreciate if you can give me a call back at my contact number *609 897 9670 Ext-2169***** ** ** *Position *:- Validation Consultant *Location *:- Medina, NY *Duration* :- 6+ Month**** ** ** *Description:* ** ** **· **Strong background in validating systems in a FDA regulated environment**** **· **Experience with validation of various systems including test script review and approval process .**** **· **Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.**** **· **Experience in Computer system validation.**** **· **Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, IQ/OQ and associated test scripts, and Validation Summary Packages )**** **· **Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.**** **· **Knowledge of FDA guidance’s and industry standards (i.e., GAMP)**** **· **Experience in HP Quality Center and QTP is preferable.**** **· **Understanding of the validation requirements and protocols including GAMP, 21 CFR part 11 and GMP**** **· **Should have done risk assessments such as 21 CFR Part11, GxP and Detailed risk assessments.**** **· **Strong knowledge in GAMP 5 software categorization and identifying the extent of testing as per the category.**** ** ** ** ** ** ** Thanks & Regards**** Vinay Kumar** Technical Recruiter**** *Email*:[email protected]**** SysMind LLC**** 38 Washington Road, Princeton Junction, NJ: 08550**** Ph:609-897-9670 x 2169 *** * [image: Description: Description: Description: Description: logo]**** -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/us_itgroups?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
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